The long-awaited final rule revising 42 CFR Part 2—the confidentiality regulation applying to substance use disorder (SUD) treatment records—is out.
The 54-page rule was published in the Federal Register on July 15, and takes effect on August 14. It follows along with the proposal, on which Filter reported last summer when the Substance Abuse and Mental Health Services Administration (SAMHSA), the agency which is supposed to protect patient confidentiality, outlined sweeping changes to the rule.
The confirmed changes allow for Opioid Treatment Programs (commonly referred to as methadone clinics) to input patient information into Prescription Drug Monitoring Programs (PDMPs), which can be accessed not only by medical professionals and pharmacists, but potentially by law enforcement.
Many patients are now likely to seek to taper off their medication.
Entering such information into PDMP databases was previously not allowed, under a 2011 “Dear Colleague” letter from SAMHSA’s Center for Substance Abuse Treatment, which regulates OTPs. Many patients believed—and still do believe—that if PDMPs find out they are on methadone, they will be penalized and discriminated against. The idea that this information will be used against them is highly plausible, given the widespread stigmatization of people on medications for opioid use disorder. As Filter has reported, many patients are now likely to seek to taper off their medication.
SAMHSA’s final rule also confirms an expansion of law enforcement access to treatment programs. Previously, law enforcement could place undercover agents or confidential informants in a treatment center, to investigate program employees or agents, for a maximum of six months. That time period has now been extended to 12 months.
Courts were previously only permitted to disclose a patient’s treatment information if it was “necessary in connection with investigation or prosecution of an extremely serious crime allegedly committed by the patient.” Now, it is no longer necessary for the crime in question to have been allegedly committed by the patient whose information is being disclosed. As Filter also reported, this is likely to result in law enforcement “fishing expeditions” against methadone patients.
Finally, the new rule further expands the definition of who can receive an SUD patient’s information. When patients consent to the release of their patient information—including the fact that they were in treatment—potential recipients of that information now fall within a much broader category than previously of healthcare operations, care coordination and case management.
The rule has been issued over patients’ objections. Observers have seen it coming for a long time.
The new SAMHSA rule follows the March 27 CARES Act, meant to alleviate some of the problems of COVID-19, which had already gutted 42 CFR Part 2. In about eight months, the CARES Act provision requiring SUD patients’ one-time consent only for the widespread, irrevocable sharing of their treatment information, will take effect. This consent will be requested, presumably, at the vulnerable time when the patient is just entering treatment and is pressured to sign, just in order to get care.
Oddly, most treatment providers back the SAMHSA changes, perhaps because they want to go with the status quo, or to integrate with the rest of medicine and get out of the SUD silo. The American Society of Addiction Medicine and the National Association of Addiction Treatment Providers have long supported this.
A few organizations—the American Association for the Treatment of Opioid Dependence (OTPs), Therapeutic Centers of America, and the National Association of Alcohol and Drug Abuse Counselors (NAADAC)—do not. Neither do patients, as their comments during last year’s public commenting period for the proposed rule-change demonstrated—despite “technical problems” conveniently and severely limiting public access to the comments.
The final rule has been issued over their objections. Observers have seen it coming for a long time.
“Will my treatment be confidential?” Substance use disorder patients would be well advised to know the answer before they ask.
Correction, July 21: This article has been edited to reflect more accurately the new rules around undercover agents and court disclosures.